Kornimate/medical-research-clean huggingface dataset:
a randomised controlled trial between two different hdr brachytherapy schedule in locally advanced carcinoma of uterine cervix

Conditions: Squamous Cell Carcinoma of Cervix

Summary: the purpose of this study is to compare two different brachytherapy treatment option in locally advanced carcinoma of uterine cervix. brachytherapy of two fractions of 9 gy is effective in locoregional control and more convenient in terms of cost and time than 7 gy brachytherapy of 3 fractions in management of locally advanced carcinoma of cervix.

cervical cancer is the second most common cancer among women worldwide and is the commonest form of gynecolgic malignancy in bangladesh.radiotherapy in the form of external beam radiotherapy combined with intracavitary brachytherapy is the accepted definitive mode of treatment.limiting the number of high dose rate(hdr) brachytherapy has the potential benefit of improving patient compliance and reducing treatment cost and duration.the aim of this study is to compare the treatment outcome and acute complications following treatment with 9 gray (gy) in two fractions of brachytherapy with standard ebrt in locally advanced carcinoma of cervix. ebrt will be delivered by a cobalt 60 teletherapy unit to a prescribed dose of 50 gy in 25 fractions of 2 gy per fraction and 5 days a week over a period of 5 weeks concurrent with inj. cisplatin 40 mg/meter square weekly for 5 weeks.the patients will be then randomised into two arms of hdr brachytherapy,either 9gy in 2 fractions or 7 gy in 3 fractions.all patients will be followed up as per guideline for 6 months.the treatment related toxicity will be measured by common toxicity criteria(common terminology criteria for adverse events v.3.0). all the relevant collected data will be compiled on a master chart and then statistical analysis of the results will be obtained by using spss 17.the data will be analysed using chi square test and t test.significant value will be decided at a level of 0.05 in two tailed tests.

Eligibility criteria:
inclusion criteria: * locally advanced carcinoma cervix (stage 2b - 4a) * histopathology squamous cell carcinoma exclusion criteria: * previous history of malignancy * previously treated with radiotherapy

Keywords: carcinoma cervix rct(randomised controlled trial) 9 gray brachytherapy
evaluating efficacy and safety of etanercept 50 mg twice weekly (biw) in rheumatoid arthritis (ra) subjects who are sub-optimal responders to etanercept 50 mg once weekly (qw)

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study objective will be to evaluate the efficacy and safety of etanercept 50 mg biw in ra subjects who showed a sub-optimal response to standard dose etanercept (50 mg qw) and concomitant methotrexate therapy.


Eligibility criteria:
inclusion criteria: * diagnosis of rheumatoid arthritis * ra with a disease duration \> 6 months * current and prior but continuous etanercept (50 mg weekly) treatment for at least 5 months prior to screening * subjects must be receiving methotrexate (mtx) at a stable dose \> 15 mg/week at least 4 weeks prior to screening * sub-optimal response to etanercept defined by the presence of the following criteria (based on 28 joint count) at screening: 5 or more swollen joints and 5 or more tender joints * subjects who are currently receiving oral corticosteroids must be on a dose equivalent to prednisone less than or equal to 10 mg/day at screening * subjects who are currently receiving non-steroidal anti-inflammatory drugs (nsaids), must be on a stable dose for at least 2 weeks prior to screening * subjects who are currently receiving dmard therapy (including sulfasalazine, hydroxy-chloroquine and leflunomide), must be on a stable dose for at least 4 weeks prior to screening exclusion criteria: * nursing mothers, female subjects planning on becoming pregnant, or male subjects planning a pregnancy with their spouse/partner while in the study * acr functional class iv * receipt of any investigational drug or biologic within 4 weeks of study drug initiation * concurrent or history of psychiatric disease that would interfere with ability to comply with study protocol or give informed consent * history of alcohol or drug abuse within 12 months of screening visit * severe comorbidities including: history of cancer (other than resected cutaneous basal and squamous cell carcinoma, and in situ cervical cancer) within 5 years of screening visit. documentation of disease-free state since treatment required; diagnosis of class iii or iv congestive heart failure (chf) or myocardial infarction (mi) within 12 months of screening; unstable or stable angina pectoris; uncontrolled hypertension (defined as systolic blood pressure measurement of greater than 180 mm hg or a diastolic blood pressure of greater than 110 mm hg); oxygen-dependent pulmonary disease; known hiv-positive status or other immunodeficiency syndromes; chronic hepatitis b (hbsag) or c (hcv); systemic lupus erythematosus (sle); cns demyelinating events suggestive of multiple sclerosis; presence of active infection or any underlying diseases that could predispose subjects to infection (e.g., history of recurrent infections, non-healing leg ulcers, advanced or poorly controlled diabetes); active or prior history of tuberculosis (or known exposure). * concurrent treatment with cyclophosphamide

Keywords: rheumatoid arthritis, ra enbrel® (etanercept) clinical trials, amgen immunex, methotrexate (mtx) rheumatoid arthritis (ra)
rebyota™ prospective registry

Conditions: Recurrence of Clostridium Difficile Infection

Summary: this is a prospective observational cohort study designed to collect data on patients who received rebyota™ for the prevention of rcdi in the routine care setting. as all data collected for this study are observational, the decision to prescribe rebyota™ is at the treating physician's discretion and independent from the decision to enroll the patient in the study. data will be collected from patients' medical records after obtaining informed consent. data about clinical history, cdi events (primary and recurrent: severity, treatment), cdi-related symptoms, treatments, medical procedures, adverse events(aes), and healthcare resource utilization (i.e., hospitalizations and re-admissions) will be collected through 6 months of follow-up from the date of rebyota™ administration.


Eligibility criteria:
inclusion criteria: * signed and dated informed consent form (icf) * age ≥ 18 years * diagnosis of rcdi as determined by the treating physician * completed antibiotic treatment for the presenting rcdi episode * prescription for rebyota™ to prevent rcdi according to the approved indication exclusion criteria: * currently enrolled in an interventional clinical trial
the prevalence of incisal angle of maxillary central incisors in adults

Conditions: Anterior Teeth

Summary: this study is to assess the prevalence of different incisal angle of maxillary central incisors in a sample of adults.materials and methods: the current study will include 300 sound natural maxillary central incisor. intraoral scan will be taken for all cases to measure the incisal angle.

this study is aimed to assess the prevalence of different incisal angle of maxillary central incisors in a sample of adults population with sound anterior central incisors. the current study will include 300 sound natural maxillary central incisor. for each, an intraoral scan will be taken to measure the incisal angle. , wither having a mesial or distal incisal angle and its degree and how frequent each one. the scans will be aligned in same xyz axis for proper standardization for the measurements.

Eligibility criteria:
inclusion criteria: * sound natural teeth exclusion criteria: * rotated teeth * pathological migration of teeth * patients subjected to trauma for anterior teeth

Keywords: anterior teeth central incisor
efficacy of an individual rehabilitation program in polymyositis and dermatomyositis

Conditions: Dermatomyositis; Polymyositis

Summary: the purpose of this study is to evaluate the efficacy of an active rehabilitation program on disability and quality of life of patients affected by dermatomyositis and polymyositis.

dermatomyositis (dm) and polymyositis (pm) are inflammatory disabling neuromuscular disorders. despite partial benefit of pharmacological treatments, muscle strength, functional status and quality of life remain impaired. although the use muscle exercises in (dm) and (pm) have been reported, its efficacy on disability and quality of life has not been proved. te aim of the study is to evaluate the benefit at mid term (12 months) of an active rehabilitation program administrated to patients affected by pm and dm. method: a 3 year prospective, multicentric, randomized controlled trial a program of 12 individual exercise sessions (3 per week during 4 weeks) is compared to conventional care. patients are followed 12 month after the inclusion.

Eligibility criteria:
inclusion criteria: * diagnosis of dermatomyositis ore polymyositis according to the international myositis assessment and clinical studies group * functional impairment (an haq score greater than 0.5) * stability of muscle impairment * medical insurance exclusion criteria: * no recent inflammatory activity * other chronic disease * cognitive impairment * patients who participated to a rehabilitation program before inclusion

Keywords: rehabilitation exercise efficacy functional status
"efficacy and safety of phlai capsule compared to placebo as the treatment in allergic rhinitis patients"

Conditions: Allergic Rhinitis

Summary: background: zingiber cassumunar roxb., frequently known as phlai in thai, has been safely used as an antihistaminic and anti-inflammatory drug in thai traditional medicine. individual with allergic rhinitis may have positive response to phlai. objective: investigators assessed the efficacy and safety of phlai as a treatment for allergic rhinitis design: the study was a 1-month, double-blind, randomized, parallel-group, intent-to-treat, multicenter, controlled trial in 267 patients at 7 hospitals in thailand. skin prick test-positive adults with allergic rhinitis ages 18 to 50 who were randomized into 3 groups (phlai 8mg/d, phlai 4mg/d, placebo). main outcome measures: primary outcome was defined: improvement of total 5 symptoms scores (nasal obstruction, rhinorrhea, sneezing, itchy nose, itchy eyes) over a 4-week interval among phlai 8mg/d, phlai 4mg/d and placebo. secondary endpoints were: assessments of rhinoconjunctivitis quality of life questionnaire, peak inspiratory nasal flow, nasal examination, adverse events, ast, alt, creatinine and bun over a period of 4 weeks.


Eligibility criteria:
inclusion criteria: * age 18-50 years old * allergic rhinitis following diagnostic criteria of aria guideline * reflective total 5 symptoms score 2-10 per day for 3 consecutive days (total score=15) and not greater than 10 in any days during the past week * positive skin prick test to at least one aeroallergen: wheal size ≥ 3 mm greater than negative control * not receiving intranasal corticosteroid + intra antihistamine for 2 weeks , intranasal corticosteroid for 2 weeks, systemic corticosteroid for 4 weeks, antihistamine for 1 week, nasal decongestant for 1 week and leukotriene receptor antagonists for 1 week exclusion criteria: * serious medical underlying diseases e.g. copd, heart disease, chronic renal failure, chronic hepatic failure * allergic rhinitis and asthma which require immunotherapy * receiving antidepressants, sedative, anxiolytic, opioids, neuroleptic * uncontrolled asthma which requires steroid inhaler, laba and does not use leukotriene receptor antagonists * previous nasal surgery for nasal polyp, nasal septum deviation * acute or chronic rhinosinusitis * pregnancy and lactation (urine pregnancy test is allowed and paid by researchers) * allergic to any kinds of herb * refusal to participation

Keywords: zingiber cassumunar phlai compound d herbal medicine allergic rhinitis
bax 855 dose-escalation safety study

Conditions: Hemophilia A

Summary: the objectives of this study are to assess the tolerability and safety after single dose treatments of bax 855 in previously treated patients (ptps) with severe hemophilia a, to determine the pharmacokinetic (pk) parameters of bax 855 compared in crossover with advate, and to evaluate the impact of anti-polyethylene glycol (peg) antibodies on pk parameters.


Eligibility criteria:
inclusion criteria: * the subject is male and is 18 to 65 years of age at the time of screening * the subject has severe hemophilia a (factor viii level \< 1%) * the subject was previously treated with plasma-derived factor viii (fviii) concentrates or recombinant fviii for at least 150 exposure days (eds) exclusion criteria: * the subject has a detectable fviii inhibitor at screening, with a titer \>= 0.6 bu * the subject has a documented history of fviii inhibitors with a titer \>= 0.4 bu at any time prior to screening * the subject has a known hypersensitivity towards mouse or hamster proteins or to polyethylene glycol (peg)
study of huperzine a sustained-release tablets in patients with alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the main purpose of this study is to evaluate the safety and efficacy of huperzine a sustained release tablets in patients with mild to moderate alzheimer's disease.

the primary aim of this multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled therapeutic trial is to determine whether treatment with huperzine a sustained-release tablets can improve cognitive function in individuals with ad. a total of 390 participants will be randomly assigned to three groups of equal size. this will allow a comparison of huperzine a sustained-release tablets 400µg once a day, huperzine a tablets 200µg twice a day, and placebo. the study is divided into 2 periods: 1. a two-week placebo run-in period 2. a 6-month double blind treatment period, consisting of three months of titration and three months of fixed dose treatment.

Eligibility criteria:
inclusion criteria: 1. male/female patient aged between 50 and 85 2. clinical diagnosis of mild to moderate probable ad based on dsm-iv and the nincds-adrda criteria 3. middle school or above: 11 ≤mmse ≤ 24, elementary school: 8 ≤ mmse ≤ 20, illiteracy: 5 ≤ mmse ≤ 16; 4. ct or mri scan excluding another structural brain disease; 5. hachinski ischemic score \< 4 6. hamilton depression scale ≤10 7. informed consent of the patient (or legal representative) and of the caregiver agreeing to take part in the study. exclusion criteria: 1. proven or clinically suspected other type of dementia such as vascular dementia, mechanic or chemical caused dementia, vitamin b12 deficiency, hypothyroidism etc. 2. epileptic patient 3. severe liver or renal disease 4. resting pulse less than 50 5. mechanical intestinal obstruction patient 6. history of stroke 7. history of angina or other severe cardiac, vascular, lung, gastrointestinal and hematopoietic system disease 8. cognitive damage caused by alcohol or substance abuse 9. disable to participate or cooperate in the protocol 10. use of any agent for the treatment of dementia within 2 weeks of randomization 11. use of another investigational agent within 3 months of screening 12. be sensitive to huperzine a or other acheis.
a study on efficacy and safety of ink cells for caebv /ebv-hlh after allo-hsct

Conditions: CAEBV (Chronic Active Epstein-Barr Virus Infection) Syndrome; EBV; Hemophagocytic Lymphohistiocytoses

Summary: to evaluate the efficacy and safety of ink cells infusion in patients with chronic active epstein-barr virus infection (caebv) and ebv-associated hemophagocytic lymphohistiocytosis (ebv-hlh) after allogeneic hematopoietic stem cell transplantation (allo-hsct)

it is a prospective, open-lable study to evaluate the efficacy and safety of ink cell infusion in caebv/ebv-hlh patients after allo-hsct. the study will enroll fifteen subjects who will receive ongoing least 4 doses of ink cells intravenously infusion after allogeneic hematopoietic stem cell transplantation. all subjects will assess the incidence of disease relapse and ebv-dna reactivation up to one year.

Eligibility criteria:
inclusion criteria: 1. patients with caebv or ebv-hlh who are eligible for allogeneic hematopoietic stem cell transplantation meet one of the following criteria: ①ebv-dna (pbmc or plasma) was still more than 103 before transplantation；②positive for cerebrospinal fluid ebv-dna； ③abnormal phenotypic lymphocytes could still be detected in bone marrow immunotyping； ④measurable ebv-related lesions on imaging； 2. ≤65 years，ecog :0-2； 3. cardiac ef≥40%, creatinine clearance ≥50%; aminotransferase（alt/ast）\<200u/l。； 4. in patients with hlh, hlh efficacy ≥partial response after prior treatment is required； 5. estimated survival time is longer than three months； 6. agree to sign the informed consent form。 exclusion criteria: 1. patients with evidence of grade ii or more serious heart disease according to the new york heart association (nyha) score (including grade ii) ; clear diagnosis of cirrhosis； 2. active infections other than ebv that have not yet been controlled； 3. positive for hepatitis b virus or hepatitis c virus； 4. active massive hemorrhage of internal organs (including gastrointestinal hemorrhage, alveolar hemorrhage, intracranial hemorrhage, etc.)； 5. also participation in other interventional clinical studies within 4 weeks
single-center trial for the validation of high-resolution transrectal ultrasound (exact imaging scanner exactvu) for the detection of prostate cancer

Conditions: Prostate Cancer

Summary: the primary objective of this study is to evaluate the performance of hr-trus in detection of prostate cancer lesions relative to whole mount section after radical prostatectomy as the reference.

the primary objective of this study is to evaluate the performance of hr-trus in detection of prostate cancer lesions relative to whole mount section after radical prostatectomy as the reference. the analysis will include the detection of all prostate cancer lesions as well as the detection of significant prostate cancer lesions. with this approach it is possible to calculate the sensitivity, specificity, negative predictive value, positive predictive value and overall accuracy of the correct detection of prostate cancer in the prostate. these results are of importance when the exactvu ultrasound scanner is to be used later for prostate cancer diagnosis using targeted biopsies.

Eligibility criteria:
inclusion criteria: 1. men \> 35 years age and \<80 years of age 2. diagnosed with prostate cancer by prostate biopsy scheduled for radical prostatectomy 3. staging by standard procedures show localized disease (\<ct4) 4. psa \< 50ng/ml 5. access to the rectum for trans rectal ultrasound 6. patient affiliated to the ''national security'' regimen or beneficiary of this regimen 7. signed written informed consent prior to any screening procedures being performed exclusion criteria: 1. patient with absence of diagnosis of prostate cancer 2. patient with metastatic prostate cancer 3. patient with rectal amputation 4. patient with contraindications for mri 5. patient in urgency situation, adult under legal protection, or unable to give his consent.

Keywords: multiparametric mri exactvu ultrasound scanner prostatectomy
characterization of the early sex hormone milieu post injury and relationship with resuscitation requirements and coagulopathy

Conditions: Traumatic Injury

Summary: traumatic injury is a major public health problem with an immense societal cost. despite improvements in trauma management, patients continue to suffer significant morbidity and mortality. evidence suggests that males and females tolerate severe injury differently with a greater protection afforded to females. determining the mechanisms responsible for these sex-based outcome differences after injury, focusing specifically on the early sex-hormone environment post-injury, may allow those at highest risk for poor outcome to be predicted and promote interventions that can improve outcomes for all injured patients. the goal of this study is to determine if the early sex hormone environment soon after injury has effects on the intensity of the immune response, resuscitation and blood transfusion requirements, and important clinical outcomes including mortality, organ failure and infection, following significant injury.


Eligibility criteria:
inclusion criteria: injury, icu admission exclusion criteria: isolated tbi, admission beyond 6 hours

Keywords: sex hormones testosterone estradiol
effects of interpersonal psychotherapy on depression during and after pregnancy

Conditions: Depression; Anxiety Disorders

Summary: this study will evaluate the impact of interpersonal psychotherapy on the course of depression during and after pregnancy, as well as its effect on infant birth outcomes.

depression is a serious illness that affects a person's body, mood, and thoughts. researchers believe that it is one of the most common complications during and after pregnancy. the following symptoms may be signs of depression during pregnancy: 2 or more weeks of depressed mood; decreased interest or pleasure in activities; change in appetite or sleep patterns; fatigue or decreased energy; difficulty concentrating; excessive feelings of guilt or worthlessness; thoughts of suicide; and extreme restlessness or irritability. depression is difficult to diagnose during pregnancy because its symptoms are sometimes confused with those of pregnancy. if left untreated, depression during pregnancy may affect not only the mother, but also the baby. specifically, the hormone changes brought on by depression may contribute to premature and low-birth-weight infants. interpersonal psychotherapy (ipt) is a short-term talking therapy that has been proven to be effective in treating depression. this study will evaluate the impact of interpersonal psychotherapy on the course of depression during and after pregnancy, as well as its effect on infant birth outcomes. this study is associated with a larger parent study. participants in this open-label study may be recruited directly for this study or through the parent study. all participants will receive 16 sessions of ipt. sessions will last approximately 50 minutes and will focus on achieving depression symptom remission by improving interpersonal functioning. the majority of ipt sessions will be held prior to delivery; up to four sessions may be held postpartum. no medication will be provided in this study, but women who are currently taking selective serotonin uptake inhibitors (ssris) at the time of study entry may continue taking their medication. participants whose symptoms do not improve with ipt will be referred to their non-study physician for further evaluation, and may begin taking ssri medication upon physician recommendation. the effects of both ipt and medication therapy will be considered when assessing outcomes. study visits will occur at 28, 32, and 36 weeks gestation, as well as weeks 1, 2, and 6, and month 6 postpartum. measurements will include cortisol levels, which will be obtained using a saliva sample, as well as depression symptom severity, which will be assessed at each ipt session. blood samples will be taken as part of the parent study.

Eligibility criteria:
inclusion criteria: * no more than 28 weeks pregnant at the time of study entry * history of depression or anxiety * current symptoms of distress * score of 9 or greater on the edinburgh postnatal depression scale (epds) * english-speaking exclusion criteria: * plans to move away from the area prior to giving birth * current use of steroids for medical conditions

Keywords: pregnancy postpartum depression